Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)

NCT07780188 | Recruiting

• 3 other identifiers: IRB#STUDY2026-0483#2681Lab Research Funds
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed "Beef+", that will emphasize the incorporation of unprocessed, lean beef (\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life

Conditions

PCOS (Polycystic Ovary Syndrome); Obese Adolescents; Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities; Overweight Adolescents; Irregular Menstrual Cycle; Irregular Menstrual Cycles; Hirsutism; Hyperandrogenism

Keywords

Dietary Intervention; Polycystic Ovary Syndrome (PCOS); Adolescents; Randomized Control Trial

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.

  Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

Secondary Outcomes (13)

• Change in 2-hour Fasting Glucose

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Dropout rate

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Change in Matsuda Index

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Change in Insulinogenic Index

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Change in Disposition Index

  Baseline and Week 12 of Intervention or Usual Lifestyle

Other Outcomes (7)

• Compliance- Lean beef intake by self-report

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Compliance - Daily Survey

  Baseline and Week 12 of Intervention or Usual Lifestyle

• Compliance - Blood Biomarkers

  Baseline and Week 12 of Intervention or Usual Lifestyle

Study Arms (2)

Control/Usual Lifestyle with optional Delayed Intervention

NO INTERVENTION

Participants randomized to usual lifestyle will continue with their usual lifestyle/ diet. Participants will undergo all scheduled study procedures. Upon completion of the 12-week of usual lifestyle, participants randomized to the delayed onset control group will be offered one month of the dietary intervention. The delayed intervention is optional.

Beef+

EXPERIMENTAL

Other: Beef+

Interventions

Beef+ OTHER

Adolescents will be instructed to consume a minimum of 1 (3oz) serving per day of cooked unprocessed, lean (\<10% fat) beef (21 oz/week) for 12 weeks. To facilitate adoption, the intervention will be offered at the household level, but it is not a requirement. The intervention is a multi-modal behavior change intervention with three overarching components: modifying beef intake, consuming beef in healthy meals, and the research team purchasing the beef needed for the intervention. To facilitate adoption of lean beef as part of a healthy diet, a study RDN will meet with the participant and at least one representative parent/guardian at bi-weekly check-ins to provide tailored dietary support and develop an implementation plan. A financial supplement of $100/month will be provided offset grocery costs.

Beef+

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female Adolescent
• years old
• Suspected or confirmed diagnosis of PCOS
• ≥1-year post-menarche
• BMI ≥85th percentile for age/height
• Able to read and speak English

You may not qualify if:

• Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)
• Unable or unwilling to eat beef
• Pregnant or planning pregnancy during study
• HbA1c ≥6.5%
• Unwilling or unable to complete study procedures
• Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)
• Conditions affecting reproductive function other than PCOS
• Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies/reactions to medical adhesives
• \- Current use of hormonal contraceptives if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M AgriLife

College Station, Texas, 77843, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Overweight; Menstruation Disturbances; Hirsutism; Hyperandrogenism

Interventions

Red Meat

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Heidi K Vanden Brink, PhD, MSc, RDMS

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi K Vanden Brink, PhD, MSc, RDMS

CONTACT

979-321-7073; heidi.vandenbrink@ag.tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician is the outcome assessor who is blinded to randomziation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)